Ostometa 4 mg/5 ml vial

Description

Indications

Ostometa is prescribed for the treatment and management of:

• Hypercalcemia of malignancy
• Bone metastases related to solid tumors
• Osteolytic lesions associated with multiple myeloma
• Corticosteroid-induced osteoporosis
• Increasing bone mass in men with osteoporosis
• Osteoporosis in postmenopausal women
• Paget’s disease of bone
• Prevention of postmenopausal osteoporosis

This medication should only be used under the supervision of a registered physician.

Pharmacology Zoledronic acid, the active ingredient in Ostometa, belongs to the nitrogen-containing bisphosphonate class. It primarily acts by inhibiting osteoclast-mediated bone resorption, showing a high affinity for mineralized bone. Once administered intravenously, it is rapidly absorbed by bone tissue. The primary molecular target of Zoledronic acid in osteoclasts is the enzyme farnesyl pyrophosphate synthase, though additional mechanisms may also contribute to its effects.

Clinical studies have demonstrated that Zoledronic acid effectively lowers serum calcium and urinary calcium excretion in cases of tumor-induced hypercalcemia. Beyond its role in bone resorption inhibition, Zoledronic acid also exhibits anti-tumor properties, anti-angiogenic effects, pain-relieving benefits, cytostatic and pro-apoptotic activity against tumor cells, and synergistic cytostatic effects when combined with other anti-cancer medications. Zoledronic acid does not accumulate in plasma after multiple doses administered every 28 days, and it is excreted unchanged through the kidneys.

Dosage

• Hypercalcemia of malignancy: A single intravenous infusion of 4 mg is recommended. No dose adjustment is needed for patients with mild-to-moderate renal impairment. If calcium levels do not normalize after the first treatment, re-administration can be considered after at least 7 days.
• Multiple myeloma and bone metastases of solid tumors: 4 mg infusion every 3-4 weeks. Patients should also take 500 mg of calcium and 400 IU of vitamin D daily.

This medication should only be taken under the guidance of a registered physician.

Administration Before administration, the concentrate from one vial must be diluted with 100 ml of calcium-free infusion solution (0.9% sodium chloride solution or 5% glucose solution). The infusion should last no less than 15 minutes. If the diluted solution is not used immediately, it should be stored at 2-8°C for no longer than 24 hours. If refrigerated, allow the solution to reach room temperature before use.

Zoledronic acid should not be mixed with calcium-containing or divalent cation-containing solutions such as Lactated Ringer’s solution. It should be infused as a single intravenous solution, separate from other medications.

This medication should only be used under the supervision of a registered physician.

Drug Interactions Ostometa has been administered alongside anticancer drugs, diuretics, antibiotics, and analgesics without reported interactions. However, caution is necessary when using Ostometa with:

• Aminoglycosides: These may prolong calcium reduction.
• Thalidomide: May increase the risk of renal dysfunction in multiple myeloma patients.
• Loop diuretics: Increases the risk of hypocalcemia.
• Nephrotoxic drugs: May elevate the risk of kidney complications.

Contraindications Ostometa should not be used in patients with:

• Hypersensitivity to Zoledronic acid, bisphosphonates, or excipients
• Severe renal impairment (Creatinine clearance <30 ml/min)
• Pregnancy and lactation

Side Effects Possible side effects include:

• Headache, nausea, loss of appetite, fatigue
• Osteonecrosis of the jaw, anemia, bone pain
• Constipation, fever, vomiting, flu-like symptoms
• Hypocalcemia, muscle pain, joint pain, hypophosphatemia

Pregnancy & Lactation Zoledronic acid is contraindicated for use during pregnancy and lactation. It is also not recommended for children and adolescents under 18 years of age.

Precautions & Warnings

• Ensure adequate hydration before administration, especially in elderly patients and those receiving diuretic therapy. Patients should drink two glasses of water before and after infusion.
• Monitor serum calcium, phosphate, magnesium, potassium, and creatinine levels after initiating therapy. Supplemental therapy may be required if deficiencies occur.
• Renal function should be closely observed.

Use in Special Populations Patients with renal impairment should follow these adjusted dosages:

• Creatinine Clearance > 60 ml/min: 4 mg (5 ml)
• Creatinine Clearance 50-60 ml/min: 3.5 mg (4.4 ml)
• Creatinine Clearance 40-49 ml/min: 3.3 mg (4.1 ml)
• Creatinine Clearance 30-39 ml/min: 3 mg (3.8 ml)

Overdose Effects In cases of overdose, symptoms such as hypocalcemia, hypophosphatemia, and hypomagnesemia may occur. These should be managed with intravenous administration of calcium gluconate, sodium or potassium phosphate, and magnesium sulfate as needed.

Therapeutic Class Bisphosphonate preparations

Reconstitution Dilute the required amount in 100 mL of 0.9% sodium chloride or 5% dextrose solution before administration.

Storage Conditions Store below 30°C before opening. Protect from moisture and light. Keep Ostometa out of reach of children.